Source: US Department of Health and Human Services – 3
The FDA has identified this recall as the most serious type.This recall involves:
removing the Pipeline Vantage 027 device models from where they are used or sold
updating instructions for using the Pipeline Vantage 021 device models
Affected Product
Product Names:
Removal of unused: Pipeline Vantage Embolization Device with Shield Technology, 027 Compatible (Pipeline Vantage 027 devices)
Instructions for Use (IFU) update: Pipeline Vantage Embolization Device with Shield Technology, 021 Compatible (Pipeline Vantage 021 Devices)
Catalog and Serial Numbers:
Removal of unused: REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PED3-027-400-14, PED3-027-400-16, PED3-027-400-18, PED3-027-400-20, PED3-027-400-25, PED3-027-400-30, PED3-027-450-12, PED3-027-450-14, PED3-027-450-16, PED3-027-450-18, PED3-027-450-20, PED3-027-450-25, PED3-027-450-30, PED3-027-450-40, PED3-027-500-14, PED3-027-500-16, PED3-027-500-18, PED3-027-500-20, PED3-027-500-25, PED3-027-500-30, PED3-027-500-40, PED3-027-550-16, PED3-027-550-18, PED3-027-550-20, PED3-027-550-30, PED3-027-550-40, PED3-027-550-50, PED3-027-600-16, PED3-027-600-18, PED3-027-600-20, PED3-027-600-30, PED3-027-600-40, PED3-027-600-50 and all Pipeline Vantage 027 product lots from B317266 through B817292
Instructions For Use (IFU) update: REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-021-300-16, PED3-021-300-20, PED3-021-275-12, PED3-021-275-16, PED3-021-325-12, PED3-021-325-14, PED3-021-325-16, PED3-021-325-20, PED3-021-250-12, PED3-021-300-14, PED3-021-250-16, PED3-021-300-12, PED3-021-275-14, PED3-021-350-14, PED3-021-350-25, PED3-021-350-12, PED3-021-250-10, PED3-021-275-20, PED3-021-350-18, PED3-021-325-18, PED3-021-275-18, PED3-021-250-18, PED3-021-300-18; and Instructions for Use, Part: M056989CDOC2. All Pipeline Vantage 021 product lots from B317266 through B817292
Unique Device Identifier (UDI)/Catalog Number:
UDI
Device Model
00847536030398
PED3-021-250-10
00847536036215
PED3-021-250-10
00847536034884
PED3-021-250-10
00847536030404
PED3-021-250-12
00847536034891
PED3-021-250-12
00847536036222
PED3-021-250-12
00847536030411
PED3-021-250-14
00847536034907
PED3-021-250-14
00847536036239
PED3-021-250-14
00847536030428
PED3-021-250-16
00847536034914
PED3-021-250-16
00847536036246
PED3-021-250-16
00847536036253
PED3-021-250-18
00847536030442
PED3-021-250-20
00847536034938
PED3-021-250-20
00847536036260
PED3-021-250-20
00847536030466
PED3-021-275-12
00847536034952
PED3-021-275-12
00847536036284
PED3-021-275-12
00847536030473
PED3-021-275-14
00847536034969
PED3-021-275-14
00847536036291
PED3-021-275-14
00847536030480
PED3-021-275-16
00847536034976
PED3-021-275-16
00847536036307
PED3-021-275-16
00847536036314
PED3-021-275-18
00847536030503
PED3-021-275-20
00847536034990
PED3-021-275-20
00847536036321
PED3-021-275-20
00847536030527
PED3-021-300-12
00847536035010
PED3-021-300-12
00847536036345
PED3-021-300-12
00847536030534
PED3-021-300-14
00847536035027
PED3-021-300-14
00847536036352
PED3-021-300-14
00847536030541
PED3-021-300-16
00847536035034
PED3-021-300-16
00847536036369
PED3-021-300-16
00847536036376
PED3-021-300-18
00847536030565
PED3-021-300-20
00847536035058
PED3-021-300-20
00847536036383
PED3-021-300-20
00847536030602
PED3-021-325-12
00847536035096
PED3-021-325-12
00847536036420
PED3-021-325-12
00847536030619
PED3-021-325-14
00847536035102
PED3-021-325-14
00847536036437
PED3-021-325-14
00847536030626
PED3-021-325-16
00847536035119
PED3-021-325-16
00847536036444
PED3-021-325-16
00847536036451
PED3-021-325-18
00847536030640
PED3-021-325-20
00847536035133
PED3-021-325-20
00847536036468
PED3-021-325-20
00847536030688
PED3-021-350-12
00847536035171
PED3-021-350-12
00847536036505
PED3-021-350-12
00847536030695
PED3-021-350-14
00847536035188
PED3-021-350-14
00847536036512
PED3-021-350-14
00847536030701
PED3-021-350-16
00847536035195
PED3-021-350-16
00847536036529
PED3-021-350-16
00847536036536
PED3-021-350-18
00847536030725
PED3-021-350-20
00847536035218
PED3-021-350-20
00847536036543
PED3-021-350-20
00847536030732
PED3-021-350-25
00847536035225
PED3-021-350-25
00847536036550
PED3-021-350-25
00847536035263
PED3-027-350-12
00847536030770
PED3-027-350-12
00847536035287
PED3-027-350-14
00847536030787
PED3-027-350-14
00847536035294
PED3-027-350-16
00847536030794
PED3-027-350-16
00847536035317
PED3-027-350-20
00847536030817
PED3-027-350-20
00847536035324
PED3-027-350-25
00847536030824
PED3-027-350-25
00847536030862
PED3-027-400-12
00847536035362
PED3-027-400-12
00847536036680
PED3-027-400-12
00847536030879
PED3-027-400-14
00847536035379
PED3-027-400-14
00847536036697
PED3-027-400-14
00847536030886
PED3-027-400-16
00847536035386
PED3-027-400-16
00847536036703
PED3-027-400-16
00847536036710
PED3-027-400-18
00847536030909
PED3-027-400-20
00847536035409
PED3-027-400-20
00847536036727
PED3-027-400-20
00847536030916
PED3-027-400-25
00847536035416
PED3-027-400-25
00847536036734
PED3-027-400-25
00847536030923
PED3-027-400-30
00847536035423
PED3-027-400-30
00847536036741
PED3-027-400-30
00847536030961
PED3-027-450-12
00847536035461
PED3-027-450-12
00847536036789
PED3-027-450-12
00847536030978
PED3-027-450-14
00847536035478
PED3-027-450-14
00847536036796
PED3-027-450-14
00847536030985
PED3-027-450-16
00847536035485
PED3-027-450-16
00847536036802
PED3-027-450-16
00847536036819
PED3-027-450-18
00847536031005
PED3-027-450-20
00847536035508
PED3-027-450-20
00847536036826
PED3-027-450-20
00847536031012
PED3-027-450-25
00847536035515
PED3-027-450-25
00847536036833
PED3-027-450-25
00847536031029
PED3-027-450-30
00847536035522
PED3-027-450-30
00847536036840
PED3-027-450-30
00847536031043
PED3-027-450-40
00847536035546
PED3-027-450-40
00847536036864
PED3-027-450-40
00847536031067
PED3-027-500-14
00847536035577
PED3-027-500-14
00847536036895
PED3-027-500-14
00847536031074
PED3-027-500-16
00847536035584
PED3-027-500-16
00847536036901
PED3-027-500-16
00847536036918
PED3-027-500-18
00847536031098
PED3-027-500-20
00847536035607
PED3-027-500-20
00847536036925
PED3-027-500-20
00847536031104
PED3-027-500-25
00847536035614
PED3-027-500-25
00847536036932
PED3-027-500-25
00847536031111
PED3-027-500-30
00847536035621
PED3-027-500-30
00847536036949
PED3-027-500-30
00847536031135
PED3-027-500-40
00847536035645
PED3-027-500-40
00847536036963
PED3-027-500-40
00847536031166
PED3-027-550-16
00847536035683
PED3-027-550-16
00847536037007
PED3-027-550-16
00847536037014
PED3-027-550-18
00847536035706
PED3-027-550-20
00847536031180
PED3-027-550-20
00847536037021
PED3-027-550-20
00847536031203
PED3-027-550-30
00847536035720
PED3-027-550-30
00847536037045
PED3-027-550-30
00847536031227
PED3-027-550-40
00847536035744
PED3-027-550-40
00847536037069
PED3-027-550-40
00847536031241
PED3-027-550-50
00847536035768
PED3-027-550-50
00847536037083
PED3-027-550-50
00847536031289
PED3-027-600-16
00847536035805
PED3-027-600-16
00847536037120
PED3-027-600-16
00847536037137
PED3-027-600-18
00847536031302
PED3-027-600-20
00847536035829
PED3-027-600-20
00847536037144
PED3-027-600-20
00847536031326
PED3-027-600-30
00847536035843
PED3-027-600-30
00847536037168
PED3-027-600-30
00847536031340
PED3-027-600-40
00847536035867
PED3-027-600-40
00847536037182
PED3-027-600-40
00847536031364
PED3-027-600-50
00847536035881
PED3-027-600-50
00847536037205
PED3-027-600-50
What to Do
Do not use and return all unused Pipeline Vantage 027 devices.
Read updated instructions before using Pipeline Vantage 021 devices.
On January 30, 2025, Medtronic Neurovascular sent all affected customers an Urgent Medical Device Recall letter recommending the following actions:
For affected Pipeline Vantage 027 devices
Do not use any affected Pipeline Vantage 027.
Remove and quarantine all unused affected products.
Return affected products to Medtronic with help from your Medtronic representative, who can also help identify suitable replacement products if needed.
For affected Pipeline Vantage 021
Download and review labeling updates M067713CDOC2 Rev. A (01/2025) (or M056989CDOC2 Rev. A) for the Pipeline Vantage 021 device. The updated Instructions for Use (IFU) was provided by Medtronic with the letter to healthcare providers and is also available on the Medtronic manuals website at: https://manuals.medtronic.com/manuals/. These instructions should be used when completing any future procedures with Pipeline Vantage 021.
The updates aim to help achieve optimal device size selection and stent braid deployment to reduce the risk of complications and patient harms by lowering the incidence of incomplete wall apposition and/or braid deformation. Revisions to the instructions include:
Considerations to appropriately select device diameter and length accounting for complex anatomy.
Techniques to deploy Pipeline Vantage compared to Pipeline Shield using a balance of device tension and compression, aiming to achieve adequate wall apposition and in complex vessel anatomies (e.g., tortuous vessels).
Warnings about the consequences of incomplete wall apposition and suboptimal deployment as well as the increased risk of braid deformation in females, especially in females younger than 45 years of age.
For all affected devices
Complete the Customer Confirmation Form included with the letter and email it to neuro.quality@medtronic.com.
For patients who have already been treated with Pipeline Vantage 027 and 021 devices
The treating physician should determine the need for follow-up imaging or changes to medical management based on the patient’s overall health. This includes weighing the risks of dual antiplatelet therapy against potential risks for braid deformation.
Reason for Recall and Updates to Use Instructions
Medtronic Neurovascular is recalling 027 Compatible Pipeline Vantage Embolization Devices and updating use instructions for 021 Compatible Pipeline Vantage Embolization Devices due to reports of a higher incidence of the flexible, braided tube part of the device failing to properly attach or stay attached to the blood vessel wall (incomplete wall apposition and/or braid deformation) during and after procedures using these devices. Incomplete wall apposition and braid deformation, also sometimes called fish-mouthing, braid narrowing, or braid collapse, are known risks of these devices. The risks were higher in females, especially those younger than 45 years of age.
The use of affected product may cause serious adverse health consequences, including thrombosis, stroke, or death.
There have been thirteen reported injuries and four reports of death related to the 027 Compatible Pipeline Vantage Embolization Device. There have been four reported injuries and no reports of death related to the 021 Compatible Pipeline Vantage Embolization Device.
Device Use
Pipeline Vantage Embolization Devices with Shield Technology are used to treat bulges in the artery walls (aneurysms) of the brain. These devices are inserted into the blood vessels (endovascular) through a small catheter and delivered to the aneurysm location, where a small, braided tube is placed to block off blood flow to the bulging area.
Contact Information
Customers in the U.S. with questions about this recall should contact their local Medtronic representative or Medtronic Quality Assurance at rs.nvquality@medtronic.com or 1-800-633-8766.
Additional FDA Resources
FDA’s Enforcement Report
Medical Device Recall Database
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
Content current as of:
03/18/2025